About CDSA: As a training academy, CDSA is mandated to build capacity and capability in the area of clinical development and translational research. We conduct training programs for young clinical researchers, ethics committee members and other personnel in becoming an efficient clinical research professional. CDSA Support Investigators and SMEs by providing Clinical Study Support Services like regulatory consultation, project management, medical monitoring, audit, data management and biostatistics. CDSA with 5 Centers of Excellence (CoEs) has formed a collegium of Centers of Clinical Research Excellence for collaboration in education, training and capacity building and Collaboration in Research, Innovation, and Clinical Development Support Services. The institutions are: KEM Hospital, Pune; Society of Applied Sciences (SAS), New Delhi; Center for Chronic Disease Control (CCDC), New Delhi; JSS University, Mysore and CMC Vellore.
Job Title: Study Monitor (Pre-Term Birth Program)
Qualification: Bachelor’s in medical sciences or Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline
Experience: At least 3-5 years of relevant clinical trial/ study monitoring experience
Job Profile:
The Study Monitor/ CRA conduct monitoring visits for assigned study protocol and study sites. Overall responsibilities are to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Performs site monitoring throughout the trial which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- Setting up the trial sites such that each centre has the trial materials, including the trial drug while ensuring all trial supplies are accounted for
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- May provide training and assistance to junior clinical staff
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
- Verifying that data entered on to the CRFs is consistent with patient clinical notes (source data/ document verification)
- Writing visit reports
- Filing and collating trial documentation and reports.
- Archiving study documentation and correspondence
- Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalates quality issues to the Quality Manager, Project Manager and/ or senior management
- Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required
Skills Required:
- Computer skills including proficiency in use of Microsoft Office applications
- Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
- Strong written and verbal communication skills including good command of English required.
- Excellent organizational and problem solving skills.
- Effective time management skills and ability to manage competing priorities
How to Apply :
- Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website.
- E-mail should be submitted with subject line Application for the post of “Clinical Data Coordinator (Surfactant Study)” to cdsa_admin@thsti.res.in
- Only shortlisted candidates will be contacted for interview
- Incomplete applications will stand summarily rejected without assigning any reasons
- The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc.. A 10% annual increase in salary is based on the performance
- This position is strictly project-based.
- All results will be published on our website and all future communications will be only through email
- Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.
- This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
- Canvassing in any form will be a disqualification.
- The last day of application is every Saturday of the week.
- If candidates are short-listed, they will be called for interview on the following Friday or other days based on the availability of interviewees.
- Those who have applied earlier need not apply again
- clikc here http://cdsaindia.in/sites/default/files/JD%20for%20Monitors%20%28PTB%29.pdf
No comments:
Post a Comment